Surgical drape sheet

ABSTRACT

A disposable surgical drape sheet, of the type having a porous nonwoven fabric sheet for placing over a surgical patient and having a fenestration near its center to expose an operative area, is provided with a continuous film of pressure-sensitive adhesive surrounding the fenestration near its center to expose an operative area. It has a continuous film of pressure-sensitive adhesive surrounding the fenestration and extending a substantial distance from the periphery. A removable abherent peel strip covering the adhesive area is removed before using the sheet, thereby exposing the adhesive and permitting the sheet to be secured around the operative area. Additionally, the adhesive fluid-proofs one side of the drape.

United States Patent Krebs [451 June 6,1972

[54] SURGICAL DRAPE SHEET [72] Inventor: Kay E. Krebs, Neenah, Wis.

[73] Assignee:

Wis.

[22] Filed: Mar. 2, 1970 [21] Appl.No.: 15,471

[52] US. Cl ..128/132 [51] Int. Cl. ..A61l 15/00 [58] Field ofSearch...128/132, 171

[56] References Cited UNITED STATES PATENTS 3,561,440 2/1971 Bayer..l28/132 D 3,503,391 3/1970 Melges ..l28/l32 D Kimberly-ClarkCorporation, Neenah,

FOREIGN PATENTS OR APPLICATIONS 148,164 12/1954 Sweden ..l28/l32 DPrimary Examiner-Lawrence Charles Att0rney-W0lfe, Hubbard, Leydig, Voit& Osann, Ltd.

[57] ABSTRACT A disposable surgical drape sheet, of the type having aporous -nonwoven fabric sheet for placing over a surgical patient andhaving a fenestration near its center to expose an operative area, isprovided with a continuous film of pressure-sensitive adhesivesurrounding the fenestration near its center to expose an operativearea. It has a continuous film of pressuresensitive adhesive surroundingthe fenestration and extending a substantial distance from theperiphery. A removable abherent peel strip covering the adhesive area isremoved before using the sheet, thereby exposing the adhesive andpermitting the sheet to be secured around the operative area.Additionally, the adhesive fluid-proofs one side of the drape.

4 Claims, 7 Drawing Figures SURGICAL DRAPE SHEET This invention relatesto surgical drape sheets, and more particularly concerns the provisionof a novel disposable drape made of porous nonwoven fabric.

Customarily, a patient who is to undergo surgery or the like is partlycovered with a drape sheet having a generally central fenestration whichexposes only the operative area. The previous use of cloth drapes forthis purpose, with their attendant initial and laundry costs and theirdifficulty in sterilization, has now largely given way to the use ofdisposable drapes.

At present, disposable drapes are of two general types, namely those ofa paper-like nonwoven fabric and those made of a plastic material. Whileboth are used, they each have well recognized limitations. Nonwovenfabric sheets, for example, are not fluid proof, thereby permitting thepatients perspiration to enter the operative field and allowing bloodand other body fluids to be discharged onto undesirable areas. Also,nonwoven disposables tend to be somewhat more slippery than textilefabrics, and the use of skin clips or the like to secure the drape isinconvenient for the surgical team and perhaps painful for the patient.On the other hand, plastic sheets are inherently fluid proof, but mosttend to be even more slippery, as well as to produce undesirable glareunder the intense operating room illumination. Additionally, there issome concern, whether or not justified, about the tendency of plasticdrapes to produce static electricity.

It has been proposed to overcome the disadvantages of plastic surgicaldrapes by utilizing adhesives to secure the drape in position. However,adhesive brushed or sprayed onto the patient is inconvenient at best,while adhesives applied to the drape during manufacture require aremovable peel strip to protect the adhesive until use. Since, in anyevent, the surgical drape must be sterilized in advance, an imperviousplastic drape on one side of the adhesive and an equally impervious peelstrip on the other effectively prevents the sterilizing medium fromreaching the adhesive.

It is accordingly an object of the present invention to provide adisposable surgical drape which integrates the advantages of nonwovenfabric drapes with regard to absence of glare, slipping, and sparkingand ease of sterilization, with the fluid-proof feature of plasticdisposables.

Another object is to provide a disposable surgical drape made ofnonwoven fabric that is securable to the patient without the need forskin clips or the like.

Still a further object is to provide a unique convenient disposablesurgical drape which may be supplied to the operating room in acompletely sterile condition.

Other and further aims, objects, and advantages of the invention willbecome apparent as the description proceeds, which description is inconjunction with the attached drawings wherein:

FIG. 1 is a plan view, looking downward, of a representative surgicaldrape according to the invention;

FIG. 2 is an enlarged sectional view, taken along line 22 of FIG. 1,showing the fenestration area, and in which the thickness of the severaldrape components is greatly exaggerated for reasons of clarity;

FIG. 3 is a somewhat enlarged fragmentary bottom view of the drape ofFIG. 1, in the condition in which it is applied to the patient;

FIG. 4 shows a partly folded pack or package of the drape, indicating inphantom the unfolded drape and the fold lines;

FIG. 5 is an end view of the partly folded drape pack depicted in FIG.4;

FIG. 6 depicts the completely folded drape of FIG. 4, again showing inphantom the original fold lines; and

FIG. 7 is a perspective of the folded drape pack as it is removed from acontainer (not shown) and made available to the surgical nurse.

While the invention will be described in connection with certainpreferred embodiments, it will be understood that it is not intended tolimit the invention to these particular embodiments. On the contrary, itis intended to cover all alternatives, modifications, and equivalents asmay be included within the spirit and scope of the invention.

Turning now to the drawings, and in particular to FIG. 1, anillustrative disposable surgical drape sheet 10 is depicted in a plan ortop view looking in a downward direction. The sheet 10 essentiallyincludes a first sheet or sheet member 11 which covers a substantialportion of the patient, and a fenestration or aperture 14 locatedgenerally in the central region of the sheet. Although surgical drapesheets within the compass of the invention may have difierent sizesdepending on whether the sheet is for laparotomy, abdominal, cystoscopy,or pediatric use, an illustrative laparotomy drape is l 18 inches longby inches wide. The fenestration 14 in this drape is ap proximately 12inches long by 4 inches wide, and is located 44 inches from the head endof the sheet and 62 inches from the foot end.

In keeping with the invention, the disposable drape I0 is made of aporous nonwoven fabric. The preparation of such fabrics form no part ofthe present invention, and essentially these materials are adhesivelybonded paper-like mats of natural or synthetic textile fibers. Themanufacture of porous nonwoven fabrics is described, for example, inBuresh, Nonwoven Fabrics" (Reinhold, 1962) and in Krcma, NonwovenTextiles" (SNTL, Prague, 1962).

As shown in FIGS. 1 and 2, the first sheet 11 is advantageously providedwith a second sheet 12. The surgical fenestration 14 is actually definedby an aperture in the second sheet 12, while a substantially largeraperture 13 is in the first sheet 11. Illustratively, the aperture 13 is1 inch away from the aperture 14, for reasons which will appear. It maybe noted at this stage, however, that the area 16 defined by the overlapof the apertures 13 and 14 contains a pressure-sensitive adhesive 17.

The second or smaller nonwoven fabric sheet 12 is coated on itsunderside (FIG. 2) with a normally tacky and pressure sensitiveadhesive. Thus, when the second sheet 12 is placed atop the first sheet11 so that the respective apertures 14, 13 are in substantial register,pressure applied to the second sheet secures the respective sheetstogether and also provides the adhesive coated area 16.

Normally tacky and pressure-sensitive adhesives for use herewith may beany of the biologically acceptable pressuresensitive adhesivesavailable. Adhesives of this class are generally composed of afilm-forming elastomeric material, typically a natural or syntheticrubber, and some type of resin or other material to impart the desireddegree of tack, wetting power, and specific adhesion. Typical resinsinclude the rosin derivatives such as hydrogenated or dehydrogenatedrosin or their esters. Various fillers, plasticizers, sterilizingagents, or

other modifiers may also be used. For further descriptions of suchadhesives, see Kirk-Othmer, Encyclopedia of Chemical Technology", SecondEdition, Vol. I, page 382 (lnterscience 1963).

To protect the adhesive-containing area extending from the periphery ofthe fenestration 14 to the aperture 13, an abherent peel strip 15 isemployed to cover at least the adhesive area 16 (FIG. 2). The peel strip15 is illustratively a plastic, heavy paper,.or nonwoven fabric havingan abherent coating, that is, a coating to which the adhesive 17 can besecured only lightly. Abherents suitable for this purpose includenatural or synthetic waxes, metal salts of fatty acids, polymericabherents such as polyethylene or silicone polymers, etc. Abherents arediscussed in Kirk-Othmers Encyclopedia, Second Edition, Vol. 1,page 1 etseq.

Turning now to FIG. 3, a patients eye view of the underside of the sheet10 is shown. The smaller or second sheet 12 is on the upper side of thefirst sheet 11, and the initial position of the peel strip 15 (FIG. 2)is indicated in phantom at 15. Between the fenestration 14 of the secondsheet 12 and the aperture of the first sheet 1 1 is, of course, acontinuous film of adhesive 17 (FIG. 2) over the area 16. Thisadhesive-coated area serves two functions: Not only does it present asterile adhesive useful for securing the surgical drape 10 in positionon the patient, but it also renders the underside of the drape l0fluid-proof in the region of the operative area.

Further, the adhesive 17 (FIG. 2) existing between the first and secondsheets 11, 12 forms a fluid-proof barrier surrounded on either side by aporous nonwoven fabric. Thus, neither perspiration nor blood or otherbody fluids can pass through the drape anywhere in the region of thesecond sheet 12, while, by reason of the porous absorbent nature of thenonwoven fabric, any fluids are protectively absorbed by the material.

When all the above advantages are not required, the surgical drape ofthe invention may omit the second sheet 12. In this event, it isnecessary only to coat an area 16 on the first sheet 11 with an adhesiveand to protect this area with a peel strip (FIG. 2).

As indicated in FIGS. 1 through 3, an aperture may be provided in thepeel strip 15 which matches, or substantially matches, the fenestration14 in the sheet 10. Alternatively, and in many instances desirably, thepeel strip 15 may have no such aperture.

Turning now to FIGS. 4 through 6, a system is shown for folding thesurgical drape 10 into a convenient pack with the peel strip 15 on thetop of the pack for easy removal in use. As indicated in FIG. 4, theinitial first sheet 11 is folded along phantom fold lines illustrated byline 19 to establish a partly folded pack the width of the initialsheet. This is further folded, as indicated generally in FIG. 6, alongphantom fold lines typified by line 20, to form the ultimate packdepicted in FIG. 7. In this latter condition, the peel strip 15 is ontop, and may be removed easily by the surgical nurse before the surgicaldrape is placed on the patient.

Thus it is apparent that there has been provided, according to theinvention, an unusually simple and low cost surgical drape sheet thatintegrates the advantages of pre-existing drapes and yet which isactually superior in many respects to woven fabric drapes. The inventivedisposable surgical drape thus fully satisfies the objectives set forthearlier.

I claim as my invention:

1. In a disposable surgical drape sheet of the type having a porousnonwoven fabric sheet for placing over a surgical patient and having agenerally central fenestration to expose the operative area, said drapesheet comprising:

a first nonwoven sheet member having a generally central aperturesubstantially larger than said fenestration;

a second, smaller, nonwoven fabric sheet member having an aperturedefining said fenestration, said second sheet member having asubstantially continuous film of normally tacky and pressure sensitiveadhesive on one side thereof to secure said first and second sheetstogether with the respective apertures in substantial register tothereby provide said substantially continuous film of adhesivesurrounding said fenestration; and

a removable adherent peel strip covering at least said continuous filmof adhesive surrounding said fenestration;

so that after removal of said peel strip and placement of said drapeover a patient, the fenestration is adhesively securable around theoperative area to prevent slipping, said film of adhesive fluid proofingone side of said drape in the region of said operative area.

2. Sheet of claim 1 folded into a pack so that said peel strip is on theoutside of said pack.

3. Sheet of claim 1 wherein said porous nonwoven fabric sheet consistsessentially of a single nonwoven sheet with said adhesive surroundingsaid fenestration therein.

4. In a disposable surgical drape sheet of the type having a nonwovenfabric sheet for placing over a surgical patient and having afenestration therein for exposing the operative area, said drape sheetcomprising, in combination:

a first sheet member having an aperture substantially larger than saidfenestration;

a second fabric sheet member having an aperture defining saidfenestration, said first and second sheet members being adhesivelybonded together;

said second sheet member having a substantially continuous film ofressure sensitive adhesive on one side thereof exposed t rough saidaperture of said first sheet member and surrounding said fenestrationand extending a substantial distance from the periphery thereof, saidrespective apertures being in substantial register.

2. Sheet of claim 1 folded into a pack so that said peel strip is on theoutside of said pack.
 3. Sheet of claim 1 wherein said porous nonwovenfabric sheet consists essentially of a single nonwoven sheet with saidadhesive surrounding said fenestration therein.
 4. In a disposablesurgical drape sheet of the type having a nonwoven fabric sheet forplacing over a surgical patient and having a fenestration therein forexposing the operative area, said drape sheet comprising, incombination: a first sheet member having an aperture substantiallylarger than said fenestration; a second fabric sheet member having anaperture defining said fenestration, said first and second sheet membersbeing adhesively bonded together; said second sheet member having asubstantially continuous film of pressure sensitive adhesive on one sidethereof exposed through said aperture of said first sheet member andsurrounding said fenestration and extending a substantial distance fromthe periphery thereof, said respective apertures being in substantialregister.